AIMSPRO® and the bladder in multiple sclerosis (MS)
| ISRCTN | ISRCTN17551402 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17551402 |
| ClinicalTrials.gov number | NCT01228396 |
| Secondary identifying numbers | DIMS04 |
- Submission date
- 07/10/2008
- Registration date
- 24/10/2008
- Last edited
- 17/07/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof James Malone-Lee
Scientific
Scientific
University College London
Whittington Hospital Campus
London
N19 5LW
United Kingdom
Study information
| Study design | Treatment, parallel-assignment, double-blind (subject, caregiver, investigator, outcomes assessor), randomised, crossover, placebo-controlled, safety/efficacy trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | A randomised, double-blind, placebo-controlled study of AIMSPRO® in secondary progressive multiple sclerosis (MS) |
| Study objectives | That AIMSPRO® will increase the average voided volume in patients with secondary progressive multiple sclerosis and overactive bladder symptoms. More details on this trial can be found on the UK MS Society Clinical Trials Database at: http://www.mssociety.org.uk/research/clinical_trials/aimspro.html |
| Ethics approval(s) | National Research Ethics Committee, National Hospital for Neurology and Neurosurgery, University College London Hospitals Foundation NHS Trust |
| Health condition(s) or problem(s) studied | Bladder dysfunction in patients with secondary progressive multiple sclerosis |
| Intervention | AIMSPRO® (manufactured by Sypharma Pty Ltd, Australia) vs placebo (cross-over trial). 1.0 ml twice weekly of AIMSPRO®/placebo for 4 weeks, injected subcutaneously, followed by a 6-week washout period and then the crossover medication for a further 4-week period. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | AIMSPRO® |
| Primary outcome measure | To determine whether the regular administration of AIMSPRO® improves bladder dysfunction, manifest as an increase in average voided volume |
| Secondary outcome measures | 1. To determine whether the regular administration of AIMSPRO® improves other manifestations of bladder dysfunction including frequency, urgency and incontinence episodes 2. To determine whether regular administration of AIMSPRO® improves general disability 3. To verify findings from a peer-reviewed uncontrolled observational study related to possible changes in colour vision in MS patients taking AIMSPRO® |
| Overall study start date | 01/11/2008 |
| Completion date | 01/03/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 20 |
| Key inclusion criteria | 1. Male and female patients aged 18 years or older 2. Men and women of childbearing potential must use adequate birth control measures for the duration of the study and should continue such precautions for 6 months after receiving the last injection of AIMSPRO® 3. Clinically definite secondary progressive multiple sclerosis 4. Ambulant, walking aids allowed 5. No more than one relapse within the last 12 months and no relapse within the last 6 months 6. Urinary frequency of 8 times per 24 hours 7. Urinary urgency with or without urge incontinence 8. Magnetic resonance imaging (MRI) brain or spinal cord abnormalities consistent with the diagnosis of MS 9. Haemoglobin >9.5 g/dL 10. White blood cells (WBC) >3.5 x 10^9/L 11. Neutrophils >1.5 x 10^9/L 12. Platelets >100 x 10^9/L 13. Baseline AST, alkaline phosphatase, thyroid function, serum electrophoresis levels must be within their normal ranges 14. Able to adhere to the study visit schedule and other protocol requirements 15. Capable of giving written informed consent. Consent must be obtained prior to any screening procedures. |
| Key exclusion criteria | 1. Acute symptomatic urinary infection 2. Taking DDAVP® for control of nocturia 3. Taking antimuscarinic agents for the control of overactive bladder symptoms 4. Full-time wheelchair user 5. History of immunosuppressant drug therapy of any kind in the last 3 months 6. Relapse within the last 6 months 7. No clear progression of disability in the last 12 months 8. Co-existent medical condition precluding participation, including any history of severe allergic reaction 9. Pregnant or lactating women and women who are planning pregnancy within 12 months of screening (i.e., approximately 6 months following last injection) 10. Receipt of any investigational drug within 30 days prior to screening or within 5 half-lives of the investigational agent, whichever is longer 11. Treatment with any therapeutic agent targeted at reducing tumour necrosis factor (TNF) (e.g., infliximab, pentoxifylline, thalidomide, etanercept, etc) within 3 months of screening 12. Previous administration of AIMSPRO® 13. Ongoing corticosteroid therapy or any corticosteroids within the previous 3 months 14. Known allergy to animal proteins 15. Known history of tuberculosis 16. Serious infections (such as pneumonia or pyelonephritis) in the previous 3 months. Less serious infections such as acute upper respiratory tract infection or simple urinary tract infection should be followed to their conclusion or treated, as appropriate, prior to inclusion 17. Opportunistic infections, including but not limited to evidence of active cytomegalovirus, active Pneumocystis carinii, Aspergillosis, histoplasmosis or atypical mycobacterium infection, etc, within the previous 6 months 18. Established malignant disease or renal, hepatic, haematologic, gastrointestinal, endocrine, pulmonary, or cardiac disease 19. A significant other neurological disorder 20. Presence of a transplanted organ, with the exception of a corneal transplant >3 months prior to screening 21. History of lymphoproliferative disease including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location (such as nodes in the posterior triangle of the neck, infra-clavicular, epitrochlear, or periaortic areas), or splenomegaly 22. Known recent clinically significant substance abuse (drug or alcohol) 23. Poor tolerability of venepuncture or lack of adequate venous access for required blood sampling during the study period 24. Investigational drugs or drugs targeted at reducing TNF - these are not allowed during participation in the study 25. Patients will not be permitted to receive immunosuppressive treatment during this study. The exception will be where a patient's treating neurologist determines that a course of steroid therapy, oral or intravenous, is required in view of a sufficiently disabling relapse of MS 26. Immunosuppressive therapy within the month prior to entry into the study 27. Taking the licensed anticonvulsant medication lamotrigine or the anti-arrhythmic drug flecainide, both of which are potent sodium channel blocking agents 28. Unable to fill in the criteria related to bladder dysfunction status 29. Unable to give written informed consent |
| Date of first enrolment | 01/11/2008 |
| Date of final enrolment | 01/03/2012 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University College London
London
N19 5LW
United Kingdom
N19 5LW
United Kingdom
Sponsor information
Daval International Ltd (UK)
Industry
Industry
4a Gildredge Street
Eastbourne
BN21 4RL
United Kingdom
| Phone | +44 (0)845 130 3014 |
|---|---|
| bryanyoul@gmail.com | |
| Website | http://www.davalinternational.com |
"ROR" |
https://ror.org/056p0fy66 |
Funders
Funder type
Industry
Daval International Ltd (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | 2016 results published in thesis: http://discovery.ucl.ac.uk/1474468/ (added 27/06/2019) |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date |
Editorial Notes
17/07/2019: IPD sharing statement added.
27/06/2019: Thesis added to publication and dissemination plan.
11/03/2019: No publications found, verifying study status with principal investigator.
21/03/2017: No publications found, verifying study status with principal investigator.
18/08/2011: The overall trial end date has again been refined, and the following end dates are now accurate:
Double-blind phase end date: May 2011.
Open-label phase: March 2012.
The previous overall trial end date was 01/10/2011.
27/10/2010: The overall trial end date has been refined, and the following end dates are now accurate:
Double-blind phase end date: February 2011.
Open-label phase: October 2011.
The previous overall trial end date was 01/11/2009.
